Lead the development and implementation of an integrated Quality Management System (QMS) covering GxP activities across GMP and GCP functions.
Oversee key quality processes including deviations, CAPA, change control, document control, training, risk management, and computerized system validation.
Drive regulatory inspection readiness, including Pre-Approval Inspections, and establish quality metrics, dashboards, and continuous improvement initiatives.
This pharmaceutical and biotechnology company is preparing for commercialization of an innovative treatment. It is a growing organization focused on building scalable quality systems, fostering a culture of quality ownership, continuous improvement, and regulatory compliance.
Lead GCP quality for clinical studies as the primary Quality point of contact from start-up through close-out.
Build the GCP quality framework, authoring SOPs, quality plans, and risk management aligned with ICH E6(R3).
Qualify and audit CROs, clinical sites, and vendors, and partner on inspection readiness.
Osanni Bio is a development-stage therapeutics platform headquartered in San Francisco, California, advancing programs in ophthalmology, cardiology, and beyond. They are a creative, agile team of innovators guided by core values of integrity, impact, agility, and collaboration.
Define and lead end-to-end quality strategy for SaMD software, AI/ML models, and connected-device products.
Own software V&V strategy, ensuring traceability and regulatory compliance across web, mobile, backend, and firmware.
Embed quality into the SDLC with shift-left practices, CI/CD gates, and automated regression testing.
Sword Health builds AI-powered healthcare care programs, using AI to heal billions and remove barriers to care. With 700,000+ members, 1,000+ enterprise clients, and $500M+ raised, Sword is a fast-paced, clinical-focused AI lab.
Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
Develop and maintain digital/software components of quality management systems, including AI quality management systems.
Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.
Own and continuously improve the Quality Management System for simulation products, programs, and services.
Serve as the primary quality liaison for customers, suppliers, and subcontractors, ensuring requirements flow down and are met.
Drive risk-based audits, CAPA activities, and root-cause analysis to improve quality performance and compliance.
Aechelon Technology, a Shield AI company, produces 3D simulator content including geospecific visual/sensor databases and realistic 3D models for pilot training. The company seeks passionate people committed to real-time computer graphics and the mission of improving pilot safety.
Lead quality strategy and AI-enabled monitoring to shift from manual audits to real-time automated controls.
Own software and operational quality by partnering with Engineering and Product on test automation and release validation.
Drive process design and cross-functional accountability to reduce error rates by 50% within the first year.
PHIL is a Series D health-tech company building a platform that connects patients, prescribers, pharmacies, and pharmaceutical manufacturers to get medication quickly and affordably. They are a dedicated team of people from a wide range of backgrounds, united by a focus on the patient experience.
Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
Build, lead, and develop a high-performing CMC Regulatory team as the company scales.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.
Lead a high-performing team of Account Partners selling global enterprise eQMS solutions to large manufacturing organizations.
Drive enterprise sales execution, coach complex deal strategy, and build long-term strategic relationships across Quality, IT, Operations, and Procurement leadership.
Meet/exceed pipeline generation and new revenue targets while ensuring accurate forecasting and expansion of multi-year agreements.
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year and became a public benefit corporation in 2021, with a culture focused on customer success, employee success, and speed.